NCT00175188

Brief Summary

The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

6.2 years

First QC Date

September 10, 2005

Last Update Submit

October 12, 2010

Conditions

Osteoarthritis

Keywords

RSADEXAOsteoarthritisFinger implantMicromotionBone densityCement

Outcome Measures

Primary Outcomes (2)

  • PIP implant migration evaluated by RSA

    2010

  • Periprosthetic bone changes evaluated by DEXA

    2010

Secondary Outcomes (1)

  • Changes in pain, grip strength, edema and range of motion

    2010

Study Arms (2)

Cemented PIP implant

ACTIVE COMPARATOR

Avanta PIP

Device: Avanta (PIP joint implant with a titanium porous coating)

Uncemented PIP implant

ACTIVE COMPARATOR

Avanta PIP

Device: Avanta (PIP joint implant with a titanium porous coating)

Interventions

Avanta (PIP joint implant with a titanium porous coating)DEVICE

Implant is inserted at the time of surgery, after written consent

Also known as: Avanta PIP implant, plasma-spray titanium coated
Cemented PIP implantUncemented PIP implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with osteoarthrosis of the PIP joints.
  • Patients with sufficient bone quality for implantation of a non-cemented prosthesis. This is estimated by the surgeon preoperatively.
  • Informed written patient consent.
  • Patients must read and understand Danish.

You may not qualify if:

  • Patients with neuromuscular or vascular diseases in the affected upper extremity.
  • Patients who, preoperatively, are found to have unsuitable bone quality for un-cemented arthroplasty fixation, for instance bone cysts not visible on x-ray.
  • Patients who cannot refrain from taking non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively including cox-2 inhibitors.
  • Patients with previously diagnosed osteoporosis.
  • Women who are pregnant or are at risk of getting pregnant during the time of investigation.
  • Patients with rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

DK(1)